Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube

Intubation Clinical Trial

Official title:

Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912105
• Other study ID #: 180-20130326
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2013
• Last updated: August 24, 2015
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Azienda Ospedaliera San Gerardo di Monza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to an ICU

• 18 years old or more

• expected to be intubated for more than 48 hours

• less than 24 hours from intubation

• fraction of inspired oxygen set at the ventilator <80%

Exclusion Criteria:

• Current or past participation in another intervention trial conflicting with the present study

• expected survival less than 24 hours

• Acute severe asthma

• Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO

• Double lumen endotracheal tube in place

• Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation)

• other contraindications posed by staff physicians

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Expected Duration of Ventilation > 48h
• Intubation

Intervention

Device:
• Airway medix closed suction system

• standard closed suctioning systems

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera San Gerardo	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Gerardo di Monza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, Bramati S, Moss J, Pesenti A. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med. 2012 Jan;40(1):119-24. doi: 10.1097/CCM.0b013e31822e9fe3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	endotracheal tube colonization	assessed by microbiologic testing of the endotracheal tube lavage fluid	within 48 hours after extubation	No
Primary	Volume of secretions	Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan	within 12 hours after extubation	No
Secondary	adverse events	report of major and minor adverse events related to the use of the device	until extubation, death or tracheostomy (approximately 2 weeks)	Yes